I-Corps: Enhanced Guidewire to Prevent Incidents of Retention in Cardiovascular Procedures

This I-Corps project is based on the development of medical device designed to prevent guidewire retention incidents during catheterization of blood vessels. In vascular procedures, a guidewire serves as a support to help guide a catheter into blood vessels, ensuring accurate and secure placement. A guidewire is used in central venous catheterization, which is a common medical procedure performed over 5 million times annually in the United States for critically ill patients. Despite clinicians’ best efforts, the procedure carries a complication rate of 12–15%, including the rare but serious event of complete guidewire retention in the body, which can lead to serious medical complications and even death in up to 20% of cases. This technology addresses this issue with a fail-safe design that reduces reliance on human vigilance. It features a P-shaped tail that externally anchors the guidewire, preventing it from unintentionally slipping into the body. This design enhances procedural safety without increasing complexity or training burden. Use of this guidewire may improve patient safety, reduce liability risks for hospitals, and result in savings in healthcare costs. This I-Corps project utilizes experiential learning coupled with first-hand investigation of the industry ecosystem to assess the translation potential of a modified guidewire designed to prevent retention incidents during central venous catheterization (CVC). CVC is a common medical procedure performed over 5 million times annually in the United States across emergency departments, intensive care units, and operating rooms for critically ill patients requiring parenteral nutrition, dialysis, and medication administration. The guidewire is designed with a rear loop in the shape of a P that acts as a physical barrier against accidental intravascular retention. The technology builds on the widely used Seldinger technique but incorporates a structural safeguard that functions independently of user behavior. Currently, guidewires do not include a built-in mechanical feature to prevent retention and rely on manual techniques that are vulnerable to human error. This technology may be integrated into existing central-line kits, creating value for medical device manufacturers, reducing liability risks for hospitals, and improving patient safety. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.